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Biological Safety Training—Madrid

About

Date/Time

Date(s) - March 6, 2023 - March 9, 2023 All Day

Location

Meliá Madrid Princesa
C. de la Princesa, 27
Madrid, 28008

*** In-person training in english***

Course A: Biocompatibility of Medical Devices – Two-Day Certification Course

Date: 6-7 March 2023
Location: Hotel Meliá Madrid Princesa
Price: $2,150 USD (early registration discount of $1,800 USD ends Sunday, 15 January 2023)

The release of ISO 10993-1:2018, 10993-18:2020 and the Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) bring new challenges for medical device manufacturers. The industry is experiencing the most drastic updates in the biological evaluation of medical devices since the issuance of the ISO 10993 standards.

This course is structured to tackle each of these challenges and provide hands-on experiential learning. It is designed for those who require a working knowledge of biocompatibility or are looking to update and sharpen their skills. Participants can expect to learn how to use standards to establish a biological safety evaluation plan, as well as how to document and implement their plan. Use of material/chemical characterization and risk assessment will be highlighted, as will real-world exercises to practice evaluating biological risk. (In order to be certified as a Biological Safety Specialist, participants must attend and complete all exercises over the 2-day course).

Course Objectives

  • Upon course completion, attendees will be able to:
    • Apply the principles of ISO 10993-1:2018 to their particular challenges with medical device biocompatibility
    • Discuss the FDA guidance for biological safety and distinguish where the FDA and other regulatory bodies differ
    • Prepare to upgrade device technical documentation to meet the European Union’s (EU) MDR 2017/745 GSPR
    • Answer the question: When is testing not the only option?
    • Distinguish the difference between evaluation and testing and recognize when testing is absolutely necessary or avoidable
    • Select chemical and biological tests and understand how to choose among various methods
    • Utilize ISO 10993-18:2020 and material/chemical characterization information with the use of toxicological risk assessment to demonstrate biological safety
    • Develop a program that guides your device on the regulatory path and reduces time to market
    • Practice how to execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan

Register for both Course A & Course B and save! 

6-9 March 2023 $3,650 USD (early registration discount of $2,950 USD ends Sunday, 15 January 2023)

NOTE: Our security measures require that your credit card billing address match your profile address.

 

Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two-Day Certification
Date: 8-9 March 2023
Location: Hotel Meliá Madrid Princesa
Price: $2,150 USD (early registration discount of $1,800 USD ends Sunday, 15 January 2023)

This two-day training course is designed for those who have received certification to the NAMSA Training Series Biocompatibility of Medical Devices – Two-Day Certification Course. Objectives of this course include practice beyond the basics of Table A.1 in ISO 10993, with increased practical application and updated workshops. In addition to traditional medical devices, we will address combination products and resorbable materials. Participants will not only learn how to assess their device for biological risks, but also understand when testing is not necessary.

Utilizing ISO 10993-17, attendees will also actively calculate safe limits with practical chemical characterization data. Additionally, instructors will provide an opportunity to work with case studies on real medical devices and provide solutions and an understanding of how to present data in a submission during the hands-on workshops. Participants will walk away with the knowledge of how to plan a strategy to endure potential obstacles.

Course Objectives

  • Upon course completion, attendees will be able to:
    • Distinguish global regulatory expectations for biological safety
    • Review reports for accurate data and work with a laboratory when unexpected results are reported
    • Evaluate complexities for drug/device combination devices
    • Calculate allowable limits for cancer, chemical mixtures and assessment of unidentified chemicals
    • Apply skills gained from two real-life exercises to calculate allowable limits and experience testing errors and how to mitigate them, as well as manage a device from concept to market clearance

Register for both Course A & Course B and save! 

6-9 Mach 2023 $3,650 USD (early registration discount of $2,950 USD ends Sunday, 15 January 2023)

 

NOTE: Our security measures require that your credit card billing address match your profile address.

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com

 

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Biological Safety Training—Madrid

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Speaker

Dr. Sylvie Framery

Senior Principal Biological Safety Scientist

Dr. Framery holds a Ph.D. in Biology and has been working for more than 15 years with NAMSA, with experience primarily focused on the pre-clinical evaluation of medical devices. Based in the French NAMSA Laboratory, she serves as Subject Matter Expert in support of Medical Research Managers and Technical Advisors. She is the author of multiple documents including Biological Safety Plans, Biological Risk Assessments, Toxicological Risk Assessments, Gap Analyses, and Expert Reports as well. She provides regularly training sessions in Europe to medical devices manufacturers and Notified Bodies. She provides consulting services to manufacturers with biocompatibility projects for worldwide market approvals and supports them during on-site meetings with regulatory authorities. She is also an active member of the ISO/TC 194 committee.

Alfred Dibao-Dina, Ph.D

Biological Safety Scientist

Alfred Dibao-Dina holds a Ph.D. degree in Biomedical Engineering. At NAMSA since 2017, he started as a Technical Advisor by providing technical and regulatory guidance to medical device’s manufacturers through preparation of quotes for consulting and testing services compliant with the international standards. His current role at NAMSA as a Biological Safety Specialist focuses on the redaction of Toxicological Risk Assessments per ISO 10993-17 and Biological Risk Assessments per ISO 10993-1 and ISO 14971. He is knowledgeable in evaluating the biocompatibility of medical devices according to the ISO 10993 series and provides regular internal and external trainings in chemical characterization according to ISO 10993:18.